Ref. no.: JO-1112-239679
Tags: regulatory regulatory affairs specialist regulatory affairs regulatory affairs advisor regulatory affairs officer
Location(s): Limerick Limerick city Munster
Salary range (€): Negotiable
Additional benefits:
Minimum experience required: 3 - 4 Years
Employment type: Permanent Full-time
Minimum qualification: See Description
Contact person: Linda Dunne
Contact e-mail: ldunne@thornshaw.com
Job description: Regulatory Affairs Specialist required for leading multinational medical device company. The successful candidate will have a thorough understanding of both the clinical trial and regulatory requirements required for the Medical Device Industry. Responsibilities of the role will include the following: • Responsibility for structuring and managing technical files. • Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820• Responsibility for structuring and managing 510(k), PMA submissions. • Responsibility for product registration in Europe, USA and other markets as appropriate. • Responsibility for registration of all Class I devices with the Irish Medicines Board. • Key member of the new product introduction and design control teams. • Liaison with the Notified Body and other relevant authorities. • Responsibility for collections and storage of clinical trials information and ensuring that the regulatory requirements are met. • Responsibility for ensuring that device labelling is correct and that they meet regulatory requirements. • Responsibility for review and approval of validation and verification documents from a regulatory view point Applications are invited from candidates with the following background and experience: • Third level Qualification in Science/Quality, at least 5 years experience in a regulated industry in a similar role. • Thorough knowledge of the FDA requirements with regard to Clinical Trials and 510K and PMA submissions. • Thorough knowledge of the EU, MDD requirements.• Thorough knowledge of the RA requirements in Canada, Australia and Japan. • Knowledge of medical device quality standards/practises or similar regulated industry • Good communication and inter-personal skills. • Proven problem-solving skills. • Good computer skills including knowledge of Microsoft® Office. • Proven organisational skills. • High self-motivation. • Approved External Auditor. • Willingness to travel on company business For further information on this role please call Linda at +353 1 2784671or email your CV in the strictest confidence to ldunne@thornshaw.comregulatory, regulatory affairs, regulatory affairs specialist, regulatory affairs officer, regulatory affairs advisor,